Federal
Register Notices > Registrant
Actions - 2007 >
The Lawsons, Inc., t/a The Medicine Shoppe Pharmacy; Denial
of Application
FR Doc E7-25346 [Federal Register: December 31, 2007 (Volume 72,
Number 249)] [Notices] [Page 74334-74339] From the Federal Register
Online via GPO Access [wais.access.gpo.gov] [DOCID:fr31de07-77]
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. 05-24]
The Lawsons, Inc., t/a The Medicine Shoppe Pharmacy; Denial of
Application
On March 4, 2005, the Deputy Assistant Administrator, Office of
Diversion Control, Drug Enforcement Administration, issued an Order to
Show Cause to The Lawsons, Inc., t/a The Medicine Shoppe Pharmacy
(Respondent) of Cheverly, Maryland. The Show Cause Order proposed the
denial of Respondent's application for a DEA Certificate of Registration
as a pharmacy on various grounds.
More specifically, the Show Cause Order alleged that in October 1999,
the Prince George's County, Maryland, Police Department received
information that Ms. Tina M. Hart-Lawson, Respondent's chief pharmacist,
was filling fraudulent prescriptions. Show Cause Order at 1. The Show
Cause Order further alleged that on multiple occasions between November
11, 1999, and February 9, 2000, two undercover officers had presented
fraudulent prescriptions for Percocet, a schedule II controlled
substance, and Vicodin, a schedule III controlled substance, to Ms.
Lawson, who filled the prescriptions without first verifying them. Id.
at 1-3. The Show Cause Order alleged that all of the prescriptions
presented by the undercover officers "had indicia of fraud'' and "were
written in the name of a fictitious doctor and DEA registration,'' and
that Ms. Lawson did not report any of the fraudulent prescriptions to
the police. Id. at 3.
The Show Cause Order also alleged that on February 4, 2000, Ms.
Lawson told one of the undercover officers that she knew that the
prescriptions presented by the officer two days earlier were forged, but
then proceeded to partially fill one of them anyway. Id. at 2. The Show
Cause Order alleged that Ms. Lawson had told the undercover officer that
a local police officer was present when the undercover officer presented
the prescriptions and had asked Ms. Lawson about them. Id. at 2-3. Ms.
Lawson allegedly told the undercover officer that because she did not
want the latter "to get in trouble,'' she told the local police officer
that the undercover officer "was a cancer patient.'' Id. at 3.
Next, the Show Cause Order alleged that on February 9, 2000, the
other undercover officer presented a fraudulent prescription for
Percocet. Id. The Show Cause Order alleged that Ms. Lawson filled the
prescription, and after being paid for it, told the undercover officer
that she "knew the prescription was fraudulent,'' but "would not call
the police'' because the undercover officer was "a sister.'' Id. The
Show Cause Order further alleged that Ms. Lawson was subsequently
arrested, and on March 8, 2002, pled guilty to having unlawfully
distributed oxycodone in violation of 21
U.S.C. 841(a)(1). Id.
Finally, the Show Cause Order alleged that on September 13, 2003,
Samuel L. Lawson, M.D., filed an application on behalf of Respondent for
a new DEA registration. Id. The Show Cause Order alleged that in support
of its application, Respondent had attached a signed statement of Ms.
Lawson which contained several material falsehoods and omissions. Id. at
3-4. The Show Cause Order thus concluded by alleging that because Ms.
Lawson "has a felony conviction and made false statements in the
Medicine Shoppe's application, granting a DEA registration to
[Respondent] would not be consistent with the public interest.'' Id. at
4.
Respondent, through its counsel, requested a hearing. The matter was
[[Page 74335]]
assigned to Administrative Law Judge (ALJ) Mary Ellen Bittner, who
conducted a hearing in Arlington, Virginia, on April 18, 2006. At the
hearing, both parties introduced documentary evidence and called
witnesses to testify. Following the hearing, both parties submitted
briefs containing proposed findings of fact, conclusions of law, and
argument.
On November 6, 2006, the ALJ issued her initial Opinion and
Recommended Decision (ALJ 1). In this decision, the ALJ concluded that
granting Respondent's application "would not be inconsistent with the
public interest.'' ALJ 1, at 19. The ALJ further noted, however, that
Respondent did not currently hold a Maryland controlled dangerous
substances license and therefore recommended the denial of its
application. Id. at 20. The ALJ further stated that in the event
Respondent obtained the state license before the record was submitted to
my office, she would change her recommendation. Id.
Thereafter, on November 27, 2006, the Government filed exceptions to
the ALJ's decision. ALJ Supplemental Decision at 2 (hereinafter, ALJ
Dec). The next day, Respondent moved for reconsideration on the ground
that it had received a state controlled-substance license. Id. On
January 10, 2007, the ALJ granted Respondent's motion, and on February
12, 2007, the ALJ issued her supplemental decision which recommended
that Respondent's application be granted. The record was then
transmitted to me for final agency action.
Having considered the entire record, I hereby issue this Decision and
Final Order. For reasons set forth below, I reject the ALJ's conclusion
that "granting Respondent's application . . . would not be inconsistent
with the public interest.'' ALJ Dec. at 19. In so holding, I adopt the
ALJ's finding "that Dr. Lawson made substantial misrepresentations in
the letter she attached to Respondent's . . . application.'' Id. I also
note that the ALJ found credible Ms. Lawson's "acknowledgments at the
hearing that she made mistakes . . . and her expressions of remorse for
those mistakes.'' Id. at 19-20. But as the ALJ also found, Ms. Lawson "provided
no testimony as to why she'' made several materially false statements in
connection with the application. Id. at 19. Thus, even if Ms. Lawson has
acknowledged her wrongdoing in filling fraudulent prescriptions, she
entirely failed to address her later misconduct in submitting a false
statement in connection with her application. Because I conclude that
the falsifications cannot be attributed to mere carelessness or
negligence, I conclude that Ms. Lawson (and Respondent) cannot be
entrusted with a registration. I make the following findings.
Findings
Respondent, a franchise of The Medicine Shoppe International, Inc.,
is a retail pharmacy located in Cheverly, Maryland. GX 1, RX 14.
Respondent is owned by Samuel Lawson, M.D., and Tina Hart-Lawson, Ph.D.
and R.Ph., who are married to each other. ALJ at 2. Ms. Hart-Lawson
began practicing as a pharmacist in 1981, Tr. 193, and was Respondent's
Chief Pharmacist in the fall of 1999 when Ms. Lawson and the pharmacy
first came to the attention of the Prince George's (P.G.) County Police
Department when the latter received information that Ms. Lawson was
knowingly filling fraudulent prescriptions. GX 14, at 1.
During the initial phase of the investigation, a DEA Diversion
Investigator (DI) went to Respondent and retrieved the prescriptions
that it had filled for a person that the P.G. County police had recently
arrested. Tr. 19. During the visit, the DI noticed that when
Respondent's customers dropped off their prescriptions, Ms. Lawson did
not verify them with their physicians. Id. at 20.
Thereafter, the DI suggested to the P.G. County Police that further
investigation of Ms. Lawson and Respondent was warranted. Id. at 20-21.
Accordingly, the investigators decided to create fictitious
prescriptions using the name of Deleon E. Ambrozewicz, M.D., and a false
DEA registration number. Id. at 21. The prescriptions also included a
telephone number, which if called, would result in the caller hearing
that the number was not available. Id. The investigators also decided to
use two persons to fill out the prescriptions and to leave out essential
information necessary to fill a prescription such as the date, the
quantity to be dispensed, and the number of refills. Id. at 47.
Between October 18, 1999, and February 9, 2000, two P.G. County
detectives carried out a total of 10 undercover visits to Respondent
during which they presented fraudulent prescriptions to Ms. Lawson. ALJ
at 4. Using the undercover name of Amber Johnson, the first detective
(hereinafter, Detective I) visited Respondent on October 18, November
11, November 16, December 1, and December 7, 1999, as well as on
February 9, 2000. Id. Using the undercover name of Colleen Talliver, the
second detective (hereinafter, Detective II) visited Respondent on
January 7, January 12, February 2, and February 4, 2000. Id.
On October 18, 1999, Detective I visited Respondent and presented to
Ms. Lawson prescriptions for Percocet and Soma,\1\ which were "issued''
under the name of Dr. Ambrozewicz. Tr. 76, GX 15. Ms. Lawson called the
telephone number on the prescription, determined that it was not a "good
number,'' and refused to fill the prescription. Tr. 75-76.
---------------------------------------------------------------------------
\1\ Soma (carisoprodol) is not a controlled drug.
---------------------------------------------------------------------------
On November 11, 1999, Detective I returned to Respondent and
presented to Ms. Lawson another fraudulent prescription for Percocet "issued''
by Dr. Ambrozewicz. Id. at 78-80. According to the Detective, Ms. Lawson
asked her only if she had insurance. Id. at 82- 83. Ms. Lawson then
filled the prescription. Id. at 81-82; see also GX 10, at 2-3.
Five days later, Detective I returned to Respondent and presented to
Ms. Lawson another fraudulent Percocet prescription "issued'' by Dr.
Ambrozewicz. Tr. 84; GX 11. On this occasion, Ms. Lawson asked the
Detective whether she had been to the pharmacy before. Tr. 84. The
Detective told Ms. Lawson that she had been there the week before to
which Ms. Lawson responded: "Oh, you must be in pain.'' Id. The
Detective answered affirmatively and Ms. Lawson filled the prescription.
Id. at 84-85; see GX 11, at 2.
On December 1, 1999, Detective I returned to Respondent and presented
to Ms. Lawson fraudulent prescriptions for both Percocet and Vicodin "issued''
by Dr. Ambrozewicz. Id. at 86. According to the Detective, Ms. Lawson
may have asked her whether she had been there before but did nothing to
verify whether the prescriptions were valid. Id. at 86-87. Moreover,
while these drugs are contraindicated, id. at 217, Ms. Lawson filled
both prescriptions. Id. at 87-88; GX 7 & 8.
Six days later, Detective I returned to Respondent and again
presented to Ms. Lawson fraudulent prescriptions for Percocet and
Vicodin "issued'' by Dr. Ambrozewicz. Tr. 88-89. According to the
Detective, Ms. Lawson asked only whether she had insurance and had been
to the pharmacy before; the Detective affirmatively answered the latter
question. Id. at 89. Ms. Lawson did nothing to verify the validity of
the prescriptions and filled both of them. Id. at 89-90; see also GXs 5
& 6.
Detective I did not return to Respondent until February 9, 2000, when
she presented to Ms. Lawson another Percocet prescription "issued'' by
Dr. Ambrozewicz. GX 9; Tr. 90-91.
[[Page 74336]]
On this occasion, Ms. Lawson told the Detective that she knew that
the prescription was "fake,'' because she had another customer who had
used the same doctor's name and had determined that the "doctor did not
exist.'' GX 14, at 2. After telling the Detective that she would let it
go this time because she had already filled the prescription, Tr. 91,
Ms. Lawson placed her telephone on its speaker-phone function and dialed
the phone number listed on the prescription. GX 14, at 2-3. Ms. Lawson
then stated: "I will let you go this time, and I'm not going to call the
police because you're a sister.'' Id. at 3; Tr. at 91. The Detective
paid cash for the Percocet and left Respondent. Tr. at 91.
On January 7, 2000, Detective II visited Respondent and presented to
Ms. Lawson a fraudulent Soma prescription "issued'' by Dr. Ambrozewicz.
Id. at 26. The prescription did not include the quantity, id.; Ms.
Lawson proceeded to ask the Detective if thirty tablets "would be
enough?'' Id. at 27. After the Detective told Ms. Lawson that thirty
tablets "would be fine,'' Ms. Lawson filled the prescription. Id. at 27.
On January 12, 2000, Detective II returned to Respondent and
presented to Ms. Lawson a fraudulent prescription for Percocet. Id. at
28. The prescription, which was "issued'' by Dr. Ambrozewicz, was
undated and left blank the number of refills. GX 12. According to the
Detective, who remained present upon tendering the prescription, Ms.
Lawson filled the prescription without verifying it. Tr. 30-31; GX 12,
at 2-3.\2\
---------------------------------------------------------------------------
\2\ On April 3, 2000, the police executed a search
warrant at Respondent and seized the various prescriptions. This
prescription bore the handwaritten notation "fraudulent.'' GX 12, at
1. According to the Detective, the notation was not on the
prescription when she tendered it to Ms. Lawson. TR. 29.
---------------------------------------------------------------------------
On February 2, 2000, Detective II returned to Respondent and
presented to Ms. Lawson fraudulent prescriptions for Vicodin and
Percocet. Tr. 32. The Vicodin prescription, which was "issued'' by Dr.
Ambrozewicz, was again undated and left blank the number of refills.\3\
GX 13, at 1. Ms. Lawson informed Detective II that because of a bad
snowstorm two days earlier, a shipment had not come in, and therefore,
she was unable to fill the Percocet prescription and could only fill
half of the Vicodin prescription. Tr. 32. Ms. Lawson then dispensed
tablets of generic Vicodin to the Detective. GX 13, at 2-3.
---------------------------------------------------------------------------
\3\ The record does not include a copy of the
Percocet prescription which Detective II presented to Ms. Lawson. The
Vicodin prescription bears the notations "forged'' and "Called 911.''
GX 13. It also included information describing the Detective's
physical appearance and automobile. See id. at 2. Ms. Lawson did not,
however, testify regarding this information. ALJ at 8.
---------------------------------------------------------------------------
On February 4, 2000, the Detective returned to Respondent in an
attempt to obtain the remaining half of the Vicodin prescription and the
Percocet prescription which had not been filled. Tr. 36. Ms. Lawson
pulled the Detective aside and told her that she knew the prescriptions
were fraudulent, and that Dr. Ambrozewicz did not exist. Id. at 36-37.
Ms. Lawson also told the Detective that during her previous visit, a
local police officer was in the store. Id. at 37. Ms. Lawson told the
Detective that "she did not say anything in front of the police
officer'' because she did not want the Detective to get in "trouble.''
GX 14, at 2; see also Tr. 37. Ms. Lawson then told the Detective that
she had only given her half the Vicodin prescription because she wanted
the Detective to leave. Tr. 37. Ms. Lawson also told the Detective that
she knew the latter needed help and hoped she would get it. Id.
Thereafter, the United States Attorney indicted Ms. Lawson. Tr. 122.
Ms. Lawson pled guilty, and, on April 29, 2002, the United States
District Court convicted her of the unlawful distribution of oxycodone
on February 9, 2000, in violation of 21
U.S.C. 841(a)(1). GX 3. Ms. Lawson was sentenced to five months
imprisonment and three years of supervised release, which also included
a five-month term of home detention. GX 3, at 2-4. Prior to entering her
plea, Ms. Lawson met with P.G. County Detectives and submitted to an
interview. Tr. 56. Moreover, at some point not specified in the record,
Respondent surrendered its DEA registration. Tr. 134.
On September 13, 2003, Respondent submitted an application for a new
registration which was completed by Respondent's husband. GX 1. On the
application, Respondent answered "yes'' to the question whether it had "ever
surrendered or had a federal controlled substance registration revoked *
* * or denied?'' GX 1, at 1. Respondent also answered "yes'' to the
question which asks a non-publicly traded corporate entity whether "any
officer, partner, stockholder, or proprietor [has] been convicted of a
crime in connection with controlled substances under state or federal
law?'' Id. In explaining its answer to the latter question, Respondent
referred to the attached statement of Ms. Lawson regarding the events
surrounding her conviction. GX 1, at 2.
In this statement, Ms. Lawson wrote:
Approximately 3 years ago (March 2000), a female patient exhibiting
excruciating pain, came to the pharmacy with a prescription for a
scheduled drug (percocet). Inspite (sic) of the fact that this patient
was extremely conniving, I followed my usual professional protocol of
verifying and authenticating the said prescription. My finding lead me
to believe that, this was a fraudulent prescription. My professional
judgment at the time on a very busy day, was to inform the police of
this occurrence. However, in order to substantiate my finding, I decided
to partial (sic) fill so that the police will apprehend the patient with
the item in hand.
For the past 20 years as a licensed pharmacist, I have turned away
several such prescriptions. On this busy day in question, I was trying
to perform my civic duty by involving the police. No sooner had I made
this professional judgement (sic), than I was later informed that this
was a set up by an agent.
Upon further investigation, it was concluded that I had performed my
duties in the past with distinction and without prior criminal record,
but the professional judgment made by me on this day in question was in
error and uncharacteristic.
Id. at 3. Upon receipt of Respondent's application, DEA commenced
this investigation.
Based on Ms. Lawson's guilty plea, on March 25, 2005, the Maryland
Board of Pharmacy charged Ms. Lawson with violating Md. Health Occ. Code
Ann. Sec. 12-313, a provision which authorizes the Board to discipline a
licensee upon a conviction or guilty plea "to a felony or to a crime
involving moral turpitude.'' RX 16, at 1. On the same day, the Board
also charged Respondent with a violation of Maryland law based on Ms.
Lawson's criminal conduct. See GX 17.
On August 1, 2005, "over the objection of the [State's] prosecutor,''
GX 16 at 2, the Board and Ms. Lawson agreed to a settlement under which
her license was "suspended for three years, with all three years
immediately [s]tayed.'' Id. at 3. The Board also placed Ms. Lawson on "probation
for a minimum of three years,'' and ordered her to complete an ethics
course. Id. at 4. Relatedly, the Board also suspended Respondent's
pharmacy permit for three years with all three years stayed and imposed
a fine of $2,500. See GX 17, at 4.
Both Mr. and Mrs. Lawson testified at the hearing. Mr. Lawson
testified that he and his wife "met on several occasions with the agents
that * * * testified'' in the proceeding, and that during these
meetings, he "was able to find out a lot of things that had happened in
terms of all the different incidents.'' Tr. 156. Mr. Lawson further
testified that the various investigations had concluded that Ms. Lawson
had received "negligible''
[[Page 74337]]
financial gain from her misconduct. Id. at 157. Mr. Lawson stated
that when the Lawsons went before the Maryland Board "the incidents that
had been put forward by DEA and also by the prosecuting attorney during
the first adjudication process, all that information was relayed * * *
to them.'' Id. at 162. Mr. Lawson also testified that to his knowledge,
his wife had not received any further complaints regarding her
dispensing of controlled substances. Id. at 172-73.
Mr. Lawson testified that a DEA diversion investigator was aware that
his wife had pled guilty to the criminal charge. Id. at 174. Mr. Lawson
also testified that another diversion investigator had "objected'' to
the answers that Respondent had provided to the liability questions (in
section 4) of the application because they did not reflect his wife's
conviction; the DI then sent him a new application and instructed him to
"fill [it] out correctly.'' Id. at 178; see also id. at 188-89. Mr.
Lawson testified that he did so, id. 179 & 189, and that the
information in his wife's statement:
was constructed by me after listening to [her] years later as to what
may have happened when the particular application that she pled guilty
to, that one count, what had transpired in my absence based, on her best
recollection. * * * I put those words together, not to mean those were
the exact things that this agent might have purported before Tina. It
was based on her physical appearance and whatever other demeanors that
she may have had on that particular day.
Id. at 179.
Mr. Lawson testified that his wife had taken continuing education
courses and completed the ethics course mandated by the Maryland Board.
Id. at 183. Mr. Lawson further testified that since the events that led
to her conviction, his wife "has been extremely cautious and she does
her best to follow all the regulations.'' Id.
Ms. Lawson testified that in the past, she "used to take [her
customer's] word,'' but that since her arrest, she had become "more
careful'' and "more suspicious of anybody that comes into the
pharmacy.'' Id. at 195. Ms. Lawson further stated that while taking the
required ethics course, she recognized that she had not been "dealing
with [her customers] on a professional basis'' because she would talk to
them about "their private life and everything,'' but now she keeps her
interactions "short and simple'' and only "deal[s] with them
professionally.'' Id. at 197.
Ms. Lawson testified that even when she fills pain medications which
are not controlled substances, she now verifies the prescription with
the prescribing physician. Id. at 198. Ms. Lawson added that she also
takes more time to fill the prescription and tells her customers that "if
they cannot wait, they can go to another pharmacy.'' Id. Ms. Lawson
further testified that she had attended a number of continuing education
courses. Id. at 200-01. Finally, Ms. Lawson testified that she "should
have done things differently and * * * I made a big error,'' and wanted
a second chance "to show [DEA] that I'm a changed person.'' Id. at 201.
Ms. Lawson offered no testimony, however, regarding the statement she
signed and submitted in support of Respondent's application. See
generally id. 191-203. Moreover, when asked by her counsel whether there
was "anything else'' she wanted the ALJ to know as to why it would be "in
the public interest to'' grant the application, Ms. Lawson answered: "I
can't think of anything right now.'' Id. at 203.\4\
---------------------------------------------------------------------------
\4\ Ms. Lawson also produced several letters of
recommendation including one from her probation officer. See RX 5.
---------------------------------------------------------------------------
On cross-examination, Ms. Lawson testified that she did not recall
the Detective who presented the prescription which led to her indictment
having ever been in her store. Id. at 211. She also testified that she
did not recall the other Detective having been in her store until
meeting the Detective during a de-briefing after her arrest. Id. Ms.
Lawson further testified that she did not remember to which Detective
she had given the partial prescription, that it had "been a very long
time [since] all these things happened,'' and that she had only a "vague
recollection of any of these prescriptions being presented to me.'' Id.
at 212. Moreover, when asked whether she knew on December 7, 1999,
whether "DeLeon Ambrozewicz was a legitimate doctor?,'' Ms. Lawson
answered: "I really don't remember. It's been a long time.'' Id. at 215.
Ms. Lawson admitted that Percocet and Vicodin are contraindicated,
but then testified that she did not remember whether she had advised
Detective II of this fact when she dispensed both drugs to her on
December 1, 1999. Id. at 216-17. Ms. Lawson also could not explain why
her pharmacy's computer-generated prescription printout indicated that
one refill was authorized for the February 2, 2000 Vicodin prescription
issued to Det. II when the initial script had left this blank. Id. at
218; see also GX 13 at 1-2. Ms. Lawson testified that she "should have *
* * checked'' the prescription and "done things differently.'' Tr. 218.
Ms. Lawson further maintained that "[i]n those days, it used to be very
busy at the pharmacy'' and that she "did not have any help,'' but that
she now "double-checks'' prescriptions, "scrutinizes anything that
leaves the pharmacy,'' and doesn't "rush.'' Id. at 219.
Discussion
Section 303(f) of the Controlled Substances Act provides that an
application for a practitioner's registration may be denied upon a
determination "that the issuance of such registration would be
inconsistent with the public interest.'' 21
U.S.C. 823(f). In making the public interest determination, the CSA
requires the consideration of the following factors:
(1) The recommendation of the appropriate State licensing board or
professional disciplinary authority.
(2) The applicant's experience in dispensing * * * controlled
substances.
(3) The applicant's conviction record under Federal or State laws
relating to the manufacture, distribution, or dispensing of controlled
substances.
(4) Compliance with applicable State, Federal, or local laws
relating to controlled substances.
(5) Such other conduct which may threaten the public health and
safety.
Id.
"These factors are * * * considered in the disjunctive.'' Robert A.
Leslie, M.D., 68 FR 15227, 15230 (2003). I "may rely on any one or a
combination of factors, and may give each factor the weight [I] deem[]
appropriate in determining whether * * * an application for registration
[should be] denied.'' Id. Moreover, I am "not required to make findings
as to all of the factors.'' Hoxie v. DEA, 419 F.3d 477, 482 (6th Cir.
2005).
Furthermore, under Section 304(a)(1), a registration may be revoked
or suspended "upon a finding that the registrant * * * has materially
falsified any application filed pursuant to or required by this
subchapter.'' 21
U.S.C. 824(a)(1). Under agency precedent, the various grounds for
revocation or suspension of an existing registration that Congress
enumerated in section 304(a), 21 U.S.C. Sec. 824(a), are also properly
considered in deciding whether to grant or deny an application under
section 303. See Anthony D. Funches, 64 FR 14267, 14268 (1999); Alan R.
Schankman, 63 FR 45260 (1998); Kuen H. Chen, 58 FR 65401, 65402 (1993).
Thus, the allegation that Respondent materially falsified its
application is properly considered in this proceeding. See Samuel S.
Jackson, 72 FR 23848, 23852 (2007).
In this case, I agree with the ALJ that Respondent and Ms. Lawson
materially
[[Page 74338]]
falsified its application for registration. ALJ Dec. at 19. While
noting that Ms. Lawson "provided no testimony as to why she'' made these
"significant misrepresentations,'' the ALJ apparently treated the
material falsification as just "other conduct'' to be considered under
Factor Five of the public interest analysis and recommended that the
application be granted. Id. at 19-20.
The ALJ's approach gave insufficient weight to Ms. Lawson's separate
act of misconduct in making several false statements in connection with
Respondent's application. Just as materially falsifying an application
provides a basis for revoking an existing registration without proof of
any other misconduct, see 21 U.S.C. Sec. 824(a)(1), it also provides an
independent and adequate ground for denying an application. Cf. Bobby
Watts, M.D., 58 FR 46995 (1993).
Ms. Lawson's statement was offered as an explanation of the events
which surrounded her dispensing of Percocet to Detective I on February
9, 2000. With respect to that statement, the ALJ concluded that Dr.
Lawson made several "false statements in the letter.'' ALJ at 19. In
particular, Ms. Lawson attempted to portray herself as the victim of
deception stating that she filled the prescription in part because the
Detective was "extremely conniving'' and exhibited "excruciating pain.''
GX 1, at 3. The Detective--whom the ALJ found credible (ALJ at
19)--testified, however, that Ms. Lawson told her that she knew that Dr.
Ambrozewicz "was a fictitious doctor,'' Tr. 91, but would "let this one
go because she had already filled the prescription'' and "was looking
out for her.'' Id.
Moreover, while Ms. Lawson represented that it was "very busy'' when
she filled the prescription, GX 1, at 3; DI Valentine testified that
both Detectives told her that "each time they went in there, it was not
busy.'' Tr. 114. Indeed, Ms. Lawson's statement to the Detective that
she knew the prescription was fraudulent but filled it because she was
looking out for her, implicated her in the criminal act of unlawful
distribution of a controlled substance. See 21
U.S.C. 841(a). This is not the type of conversation that one would
expect to occur in a "very busy'' pharmacy.
The evidence thus establishes that Ms. Lawson was neither duped into
filling the prescription nor harried by the demands of a "very busy''
work environment. I thus find that her representations that the
Detective was "conniving'' by exhibiting "excruciating pain'' and that
the pharmacy was "very busy'' were false.
Ms. Lawson further asserted that her "professional judgment at the
time * * * was to inform the police of this occurrence,'' and that "to
substantiate [her] finding'' that the prescription was fraudulent, she "decided
to partial[ly] fill [the prescription] so that the police will apprehend
the patient with the item in hand.'' GX 1, at 3. As the ALJ found, there
is no evidence that Ms. Lawson contacted the police on the date in
question, February 9, 2000.\5\ Indeed, as recounted in the police
report, Ms. Lawson put her telephone on its speaker function so that the
Detective could hear, dialed the number for Dr. Ambrozewicz (to show
that she knew that there was no such doctor) and stated: "see, I will
let you go this time, and I'm not going to call the police because
you're a sister.'' GX 14, at 3. I thus find that Ms. Lawson's
representations that it was her judgment "to inform the police'' and
that she filled the prescription "so that the police [would] apprehend
the patient with the item in hand'' were both false.
---------------------------------------------------------------------------
\5\ In discussing this part of Ms. Lawson's
statement, the ALJ also noted that "Detective Muldoon testified to Dr.
Lawson's statement that she partially filled the prescription so that
Detective Muldoon would not get in trouble with the police.'' ALJ at
19. Detective Muldoon's statement was, however, in reference to the
February 2 and 4, 2000 undercover visits, and not to Ms. Lawson's
criminal conduct on February 9, 2000. Ms. Lawson was indicted for, and
convicted of, only her conduct on February 9, 2000; her written
statement was offered only in explanation of the events pertaining to
her conviction. Detective Muldoon's statements are therefore not
probative of the events occurring on this date. Accordingly, I reject
the ALJ's reasoning to the extent it relied on the statement to
Detective Muldoon in finding that Ms. Lawson's statement was false.
---------------------------------------------------------------------------
Having found that these various statements were false does not,
however, close the inquiry because it must also be determined whether
they were material. "The most common formulation'' of the concept of
materiality "is that a concealment or misrepresentation is material if
it `has a natural tendency to influence, or was capable of influencing,
the decision of the decisionmaking body to which it was addressed.''
Kungys v. United States, 485 U.S. 759, 770 (1988) (quoting Weinstock v.
United States, 231 F.2d 699, 701 (D.C. Cir. 1956)) (other citation
omitted); see also United States v. Wells, 519 U.S. 482, 489 (1997)
(quoting Kungys, 485 U.S. at 770). The evidence must be "clear,
unequivocal, and convincing.'' Kungys, 485 U.S. at 772. However, "the
ultimate finding of materiality turns on an interpretation of
substantive law.'' Id. at 772 (int. quotations and other citation
omitted).
DEA has previously held that "[t]he provision of truthful information
on applications is absolutely essential to effectuating [the] statutory
purpose'' of determining whether the granting of an application is
consistent with the public interest. See Peter H. Ahles, 71 FR 50097,
50098 (2006). As the Sixth Circuit recently observed: "Candor during DEA
investigations * * * is considered by the DEA to be an important factor
when assessing whether a * * * registration is consistent with the
public interest.'' Hoxie v. DEA, 419 F.3d 477, 483 (6th Cir. 2005).
An applicant's answers to the various liability questions are
material because this Agency "relies upon such answers to determine
whether an investigation is needed prior to granting the application.''
Martha Hernandez, M.D., 62 FR 61145, 61146 (1997). The explanation given
by an applicant who has affirmatively answered a liability question is
likewise material because the public interest inquiry under section
303(f) requires, inter alia, that the Agency examine "[t]he applicant's
experience in dispensing * * * controlled substances,'' its "conviction
record * * * relating to the * * * dispensing of controlled
substances,'' and its "[c]ompliance with applicable State, Federal, or
local laws relating to controlled substances.'' 21
U.S.C. Sec. 823(f). Moreover, even where, as here, an applicant (or
its related person) has been convicted of a controlled-substance related
offense, that conviction does not impose a per se bar to the granting of
a new registration. See, e.g., Scott H. Nearing, D.D.S., 70 FR 33200
(2005). Rather, in evaluating such applications, the Agency looks at
several factors including the egregiousness of the applicant's criminal
conduct, its mitigating evidence, and whether the applicant has accepted
responsibility for its prior criminal conduct. See id.; see also
Jackson, 72 FR at 23853.
While Ms. Lawson's misrepresentations were somewhat inconsistent in
that they depicted her as a victim of a "conniving'' customer and the
circumstance of a "very busy'' store, while then claiming that she
filled the prescription so that police could apprehend the customer with
the drugs in hand, I conclude that the statements were made to present
her criminal conduct as less serious than it actually was. The
statements were material because they had "a natural tendency to
influence,'' or were "capable of influencing'' the Agency's evaluation
of several of the public interest factors and the ultimate decision as
to whether the Agency should grant Respondent's
[[Page 74339]]
application.\6\ Kungys, 485 U.S. at 770 (internal quotations and
other citations omitted).
---------------------------------------------------------------------------
\6\ My decision in Jackson is not to the contrary.
In Jackson, I found that the respondent provided a factually accurate
disclosure of his conviction; this act thus rendered immaterial the
respondent's "no'' answer to question of whether he had been convicted
of a controlled substance offense. 72 FR at 23852-53. Similarly,
respondent's statement that he had voluntarily surrendered his
registration when it had actually been revoked was not consequential
in light of fact that no regulation defines the difference between the
terms and the respondent had provided an accurate disclosure of the
conduct that led to the loss of his registration. Id. In addition, I
also adopted the ALJ's finding that the respondent had not
intentionally falsified his application. Id. at 23852.
---------------------------------------------------------------------------
That the Agency did not rely on Ms. Lawson's false statements and
grant Respondent's application does not make the statements immaterial.
As the First Circuit has noted with respect to the material
falsification requirement under 18 U.S.C. Sec. 1001, "[i]t makes no
difference that a specific falsification did not exert influence so long
as it had the capacity to do so.'' United States v. Alemany Rivera, 781
F.2d 229, 234 (1st Cir. 1985). See also United States v. Norris, 749
F.2d 1116, 1121 (4th Cir. 1984) ("There is no requirement that the false
statement influence or effect the decision making process of a
department of the United States Government.'').\7\
---------------------------------------------------------------------------
\7\ The fact that a DEA Diversion Investigator from
a local field office may have been present when Ms. Lawson entered her
plea, Tr. 174, also does not render her representations immaterial. As
the ALJ found, Respondent's application was submitted to a different
section of the Agency, ALJ at 11, where it was initially reviewed.
---------------------------------------------------------------------------
I further conclude that Ms. Lawson's material falsifications cannot
be attributed to mere negligence or carelessness, and that she either "knew
or should have known'' that the statements were false. Dan E. Hale, D.O.,
69 FR 69402, 69406 (2004); The Drugstore, 61 FR 5031, 5032 (1996). The
circumstances surrounding the February 9, 2000 visit, in which Ms.
Lawson indicated that she knew the prescription was fraudulent and
proceeded to dial the phone number of Dr. Ambrozewicz to demonstrate to
the Detective that she knew that the doctor did not exist, are
sufficiently different from the typical filling of a prescription that
one should accurately recall them. Furthermore, the experience of being
indicted and pleading guilty in a federal district court to the unlawful
distribution of Percocet on the above date are of such significance that
one should have a fairly accurate recollection of the underlying
circumstances. Moreover, only three and a half years had elapsed between
her criminal conduct in filling the fraudulent prescription and her
submission of the statement. Significantly, Respondent provided the
statement to DEA after the rejection of an earlier application.
I further note that Ms. Lawson did not testify regarding the
circumstances surrounding the preparation of the statement. Ms. Lawson's
failure to testify on the issue supports an adverse inference that she
knew the statements were false. See Wiliam M. Knarr, 51 FR 2772, 2773
(1986). Cf. Baxter v. Palmigiano, 425 U.S. 308, 319 (1976). Both the
circumstantial evidence and Ms. Lawson's silence thus support the
conclusion that she knowingly made false statements in an attempt to
obtain a favorable decision from the Agency on Respondent's application.
I recognize that the ALJ found that Ms. Lawson credibly acknowledged "that
she made mistakes'' and expressed "remorse for those mistakes.'' ALJ
Dec. at 19-20. But because Ms. Lawson did not address the issues
surrounding the material falsification of her statement, the ALJ's
findings are relevant only with respect to the issues related to
Respondent's dispensing's of controlled substances to the two
Detectives.
Because Ms. Lawson failed to offer any explanation as to why she
submitted her statement, I further conclude that she has not accepted
responsibility and expressed remorse for the separate act of misconduct
that she committed in submitting her written statement. Her failure to
do so precludes a finding that granting Respondent a new registration
would be consistent with the public interest.
Order
Pursuant to the authority vested in me by 21
U.S.C. Sec. 823(f), as well as 28 CFR 0.100(b) & 0.104, I order
that the application of The Lawsons, Inc., t/a The Medicine Shoppe
Pharmacy, for a DEA Certification of Registration as a pharmacy, be, and
it hereby is, denied. This order is effective January 30, 2008.
Dated: December 13, 2007.
Michele M. Leonhart,
Deputy Administrator.
[FR Doc. E7-25346 Filed 12-28-07; 8:45 am]
BILLING CODE 4410-09-P
NOTICE: This is an
unofficial version. An official version of these publications may be obtained
directly from the Government Printing Office (GPO).
|